Use

This test is an in vitro nucleic acid amplification test for the detection of RNA from microorganisms associated with vulvovaginal candidiasis and trichomoniasis. The assay utilizes real‑time transcription‑mediated amplification (TMA) to detect and qualitatively report results for the following organisms: Candida species group (C. albicans, C. tropicalis, C. parapsilosis, C. dubliniensis), Candida glabrata, and Trichomonas vaginalis. The assay is intended to aid in the diagnosis of vulvovaginal candidiasis and trichomoniasis using clinician‑collected and patient‑collected vaginal swab specimens from individuals with a clinical presentation consistent with vaginitis or vulvovaginitis.